A Phase IIb Study to Evaluate a Long-Acting Intramuscular... | NCT02120352 | Trialant
NCT02120352
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Jun 12, 2024Actual
Enrollment
309Actual
Phase
Phase 2
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Interventions
CAB Oral Tablets
CAB LA
ABC/3TC Oral tablets
RPV Oral Tablets
HAART
RPV
Countries
United States
Canada
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT02120352
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
200056
Secondary IDs
ID
Type
Description
Link
2013-000783-29
EudraCT Number
Brief Title
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
Official Title
A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 Plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of GSK1265744 Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Jun 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 28, 2014Actual
Primary Completion Date
Aug 13, 2015Actual
Completion Date
Apr 20, 2023Actual
First Submitted Date
Apr 17, 2014
First Submission Date that Met QC Criteria
Apr 21, 2014
First Posted Date
Apr 22, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 15, 2020
Results First Submitted that Met QC Criteria
Aug 14, 2020
Results First Posted Date
Aug 31, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 10, 2015
Certification/Extension First Submitted that Passed QC Review
Dec 10, 2015
Certification/Extension First Posted Date
Jan 13, 2016Estimated
Last Update Submitted Date
Jun 11, 2024
Last Update Posted Date
Jun 12, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
Janssen Pharmaceuticals
INDUSTRY
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278.
The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.
The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
Detailed Description
Not provided
Conditions Module
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Keywords
bi-monthly
GSK744
injectable
long acting
maintenance
abacavir
every other month
rilpivirine
HIV-1 infection
integrase inhibitor
TMC278 LA
RPV
non-nucleoside reverse transcriptase inhibitor
LA
once monthly
GSK1265744
induction
treatment satisfication
once daily
lamivudine
adherence
TMC278
therapy-naive
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
309Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
Experimental
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Drug: CAB LA
Drug: RPV
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Experimental
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Drug: CAB LA
Drug: RPV
CAB 30 mg+ABC/3TC QD (Induction Period)
Active Comparator
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
Drug: CAB Oral Tablets
Drug: ABC/3TC Oral tablets
Drug: RPV Oral Tablets
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CAB Oral Tablets
Drug
White to almost white oval shaped film coated 30 mg tablets for oral administration.
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).
Week 32
Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.
Up to Week 32
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Percentage of participants with HIV-1 RNA <200 c/mL and <50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects screened for this study must be HIV-1 infected and >=18 years of age.
A female subject is eligible to enter and participate in the study if she: is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or; is of child-bearing potential with a negative pregnancy test at both Screening and first day of the Induction Period and agrees to use one of the following methods of contraception to avoid pregnancy 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of GSK744 LA and TMC278 LA: Complete abstinence from intercourse (where this is the subject's preferred and usual lifestyle); double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); approved hormonal contraception; any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year; male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; any other method with published data showing that the lowest expected failure rate is <1% per year; any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study must follow safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide) to minimize risk of HIV transmission.
HIV-1 infection as documented by Screening plasma HIV-1 RNA>=1000 c/mL.
CD4+ cell count >=200 cells/mm^3 (or higher as local guidelines dictate).
ART-naive defined as having no more than 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection. Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion Criteria:
Women who are breastfeeding.
Any evidence at screening of an active Center for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.
Subjects with known moderate to severe hepatic impairment.
Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject.
Subject who, in the investigator's judgment, poses a significant suicide risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.
The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic Hepatitis B virus (HBV) infection (HBsAg positive). Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require such therapy during the randomized portion of the study must be excluded.
History of liver cirrhosis with or without hepatitis viral co-infection.
Ongoing or clinically relevant pancreatitis.
History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.
Personal or known family history of prolonged QT syndrome.
Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to receive study medication.
History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
Current or anticipated need for chronic anti-coagulation.
Any evidence of primary resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result.
Any verified Grade 4 laboratory abnormality.
Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound.
Subject has estimated creatinine clearance <50 mL/min via Cockcroft-Gault method.
Alanine aminotransferase (ALT) >=5 times Upper limit of normal (ULN). Subjects with ALT >2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and GlaxoSmithKline (GSK) medical monitor the lab abnormality will not interfere with the study procedures or compromise subject safety.
Alanine aminotransferase (ALT) >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin).
Any clinically significant finding on screening or Baseline electrocardiograph (ECG), specifically: Heart rate <45 and >100 beats per minute (bpm) (Males) and <50 and >100 bpm (Females) (100 to 110 bpm can be rechecked within 30 minutes to verify eligibility), QRS duration >120 milliseconds (msec), QTc interval (B or F) >450 msec; non-sustained (>=3 consecutive beats) or sustained ventricular tachycardia; sinus pauses >2.5 seconds; 2nd degree (Type II) or higher atrio-ventricular (AV) block; evidence of WPW (Wolff- Parkinson-White) syndrome (ventricular pre-excitation); pathologic Q waves defined as Q wave >40msec OR depth >0.4 mV; any significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator and GSK medical monitor, will interfere with the safety for the individual subject.
Subjects who are human leukocyte antigen (HLA)-B*5701 positive and unable to use an alternative nucleoside reverse transcriptase inhibitor (NRTI) backbone (subjects who are HLA-B*5701 positive may be enrolled if they use an alternative NRTI backbone that does not contain abacavir).
Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.
Treatment with any of the following agents within 28 days of Screening; radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy and Immunomodulators that alter immune responses (such as systemic corticosteroids, interleukins, or interferons)
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP.
Kerrigan D, Mantsios A, Gorgolas M, Montes ML, Pulido F, Brinson C, deVente J, Richmond GJ, Beckham SW, Hammond P, Margolis D, Murray M. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018 Jan 5;13(1):e0190487. doi: 10.1371/journal.pone.0190487. eCollection 2018.
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Study consisted of 28 days Screening Period, 20 weeks Induction Period, 96 weeks Maintenance Period (MP), Extension Period (EP) and 52 weeks Long-Term Follow Up Period (LTFP). A total of 309 participants were enrolled in the study and entered the Induction Period, of which 288 completed and 286 were qualified and randomized into the MP.
Recruitment Details
The study was conducted across 50 sites in five countries (United States, Canada, France, Germany and Spain). The results presented are based on final analysis, up to approximately Week 468.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
Periods
Title
Milestones
Reasons Not Completed
Induction Period (20 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 16, 2017
Feb 3, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Active Comparator
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Drug: CAB Oral Tablets
Drug: ABC/3TC Oral tablets
Drug: RPV Oral Tablets
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
Experimental
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
Drug: CAB LA
Drug: RPV
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Experimental
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
Drug: CAB LA
Drug: RPV
Long-Term Follow-Up Group
Other
This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
Other: HAART
CAB 30 mg+ABC/3TC QD (Induction Period)
CAB LA
Drug
Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
ABC/3TC Oral tablets
Drug
ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
CAB 30 mg+ABC/3TC QD (Induction Period)
RPV Oral Tablets
Drug
Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
CAB 30 mg+ABC/3TC QD (Induction Period)
HAART
Other
Higly-active antiretroviral therapy chosen by participant based on investigator recommendations and based on availability.
Long-Term Follow-Up Group
RPV
Drug
Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
Up to 20 weeks
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.
Up to an average of 59 weeks
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.
Up to an average of 59 weeks
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters
Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Up to an average of 59 weeks
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Up to an average of 59 weeks
Number of Participants With Post-Baseline Urinalysis Dipstick Results
Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented.
Week -20, Week -16, Week -12, Week -4, Day 1
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Up to 20 Weeks
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Up to Week 20
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Up to 20 weeks
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period)
Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period)
Percentage of participants with HIV-1 RNA <50 c/mL and <200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders.
From Day 1 up to Week 96
Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period)
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.
At Week 32 and Week 48
Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)
Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented. SD=0.000 is defined as following: if participants analyzed at a specific timepoint have resulted same values, then SD is considered equal with 0.000.
At Week 32 and Week 96
Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)
Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.
At Week 32 and Week 96
Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period)
HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
At Week 32 and Week 96
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Up to Week 32
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Up to Week 96
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
At Week 32 and Week 96 (compared with Baseline [Week -20])
Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data.
Up to Week 32
Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated.
Up to Week 32
Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
Pre-dose on Weeks 16, 24 and 32
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
Pre-dose on Weeks 16, 20, 24, 28 and 32
Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
Pre-dose on Weeks 16, 24 and 32
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
Pre-dose on Weeks 16, 20, 24, 28 and 32
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC [0-tau]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).
Standard Error (SE)=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000 .
Up to Week 32
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
Up to Week 32
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
Up to Week 32
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).
SE=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000.
Up to Week 32
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
Up to Week 32
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
Up to Week 32
Number of Participants With Treatment-emergent Genotypic Resistance
Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor [NRTI], Non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI])are presented.
Up to Week 32
Number of Participants With Treatment-emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant.
Up to Week 32
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period)
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).
Up to Week 32
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period)
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).
Up to Week 32
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period)
The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
At Week 32 and Week 96
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period)
The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.
Week 32
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period)
The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented.
Week 32
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period)
The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 96 by their score categories (0: none of the time to 6: all of the time) are presented.
Week 96
Bakersfield
California
93301
United States
GSK Investigational Site
Beverly Hills
California
90211
United States
GSK Investigational Site
Long Beach
California
90813
United States
GSK Investigational Site
Los Angeles
California
90069
United States
GSK Investigational Site
Denver
Colorado
80246
United States
GSK Investigational Site
Fort Lauderdale
Florida
33316
United States
GSK Investigational Site
Ft. Pierce
Florida
34982
United States
GSK Investigational Site
Savannah
Georgia
31401
United States
GSK Investigational Site
Minneapolis
Minnesota
55415
United States
GSK Investigational Site
Omaha
Nebraska
68198
United States
GSK Investigational Site
Chapel Hill
North Carolina
27514
United States
GSK Investigational Site
Providence
Rhode Island
02904
United States
GSK Investigational Site
Austin
Texas
78705
United States
GSK Investigational Site
Dallas
Texas
75246
United States
GSK Investigational Site
Vancouver
British Columbia
V6Z 2C7
Canada
GSK Investigational Site
Winnipeg
Manitoba
R3A 1R9
Canada
GSK Investigational Site
Ottawa
Ontario
K1H 8L6
Canada
GSK Investigational Site
Toronto
Ontario
M5G 1K2
Canada
GSK Investigational Site
Montreal
Quebec
H2L 4E9
Canada
GSK Investigational Site
Montreal
Quebec
H2L 4P9
Canada
GSK Investigational Site
Montreal
Quebec
H3A 1T1
Canada
GSK Investigational Site
Montreal
Quebec
H4A 3J1
Canada
GSK Investigational Site
Bobigny
93009
France
GSK Investigational Site
Lyon
69437
France
GSK Investigational Site
Marseille
13274
France
GSK Investigational Site
Nantes
44093
France
GSK Investigational Site
Nice
06202
France
GSK Investigational Site
Paris
75018
France
GSK Investigational Site
Paris
75571
France
GSK Investigational Site
Paris
75970
France
GSK Investigational Site
Saint-Denis
93205
France
GSK Investigational Site
Munich
Bavaria
80337
Germany
GSK Investigational Site
Frankfurt am Main
Hesse
60596
Germany
GSK Investigational Site
Hanover
Lower Saxony
30625
Germany
GSK Investigational Site
Bonn
North Rhine-Westphalia
53127
Germany
GSK Investigational Site
Berlin
10439
Germany
GSK Investigational Site
Berlin
10787
Germany
GSK Investigational Site
Berlin
13353
Germany
GSK Investigational Site
Hamburg
20146
Germany
GSK Investigational Site
Hamburg
20246
Germany
GSK Investigational Site
Badalona
08916
Spain
GSK Investigational Site
Barcelona
08025
Spain
GSK Investigational Site
Barcelona
08036
Spain
GSK Investigational Site
Barcelona
08907
Spain
GSK Investigational Site
Elche
?03203
Spain
GSK Investigational Site
Madrid
28007
Spain
GSK Investigational Site
Madrid
28040
Spain
GSK Investigational Site
Madrid
28041
Spain
GSK Investigational Site
Madrid
28046
Spain
Derived
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Smith GHR, Henry WK, Podzamczer D, Masia MDM, Bettacchi CJ, Arasteh K, Jaeger H, Khuong-Josses MA, Montes-Ramirez ML, Stellbrink HJ, Yazdanpanah Y, Richmond GJ, Sutton KC, Zhang F, McCoig CC, St Clair MH, Vandermeulen K, Van Solingen-Ristea R, Smith KY, Margolis DA, Spreen WR. Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. eCollection 2021 Sep.
Letendre SL, Mills A, Hagins D, Swindells S, Felizarta F, Devente J, Bettacchi C, Lou Y, Ford S, Sutton K, Shaik JS, Crauwels H, D'Amico R, Patel P. Pharmacokinetics and antiviral activity of cabotegravir and rilpivirine in cerebrospinal fluid following long-acting injectable administration in HIV-infected adults. J Antimicrob Chemother. 2020 Mar 1;75(3):648-655. doi: 10.1093/jac/dkz504.
Murray M, Pulido F, Mills A, Ramgopal M, LeBlanc R, Jaeger H, Canon V, Dorey D, Griffith S, Mrus J, Spreen W, Margolis D. Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. HIV Res Clin Pract. 2019 Aug-Oct;20(4-5):111-122. doi: 10.1080/25787489.2019.1661696. Epub 2019 Sep 18.
Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, Lutz T, Angel JB, Richmond GJ, Clotet B, Gutierrez F, Sloan L, Clair MS, Murray M, Ford SL, Mrus J, Patel P, Crauwels H, Griffith SK, Sutton KC, Dorey D, Smith KY, Williams PE, Spreen WR. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017 Sep 23;390(10101):1499-1510. doi: 10.1016/S0140-6736(17)31917-7. Epub 2017 Jul 24.
FG001
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
FG002
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
FG003
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
FG004
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
FG005
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
FG006
Long-Term Follow-Up Group
This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
FG000309 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000288 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00021 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lack of Efficacy
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Met protocol-defined stopping criteria
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period (Up to Week 96)
Type
Comment
Milestone Data
STARTED
2 participants did not enter Maintenance phase as they had Day 1 viral loads >50 copies/milliliter.
FG0000 subjects
FG001115 subjects
FG002115 subjects
FG00356 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG001110 subjects
FG002101 subjects
FG00347 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0015 subjects
FG00214 subjects
FG0039 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0028 subjects
FG003
Extension Period (Week 97 to Study End)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001107 subjects
FG002101 subjects
FG0030 subjects
FG00434 subjects
FG00510 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG00192 subjects
FG00276 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00115 subjects
FG00225 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
FG00211 subjects
FG003
Long-Term Follow-up Period (52 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00643 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
309 participants are valid only for the Induction Phase of the study (Weeks -20 to Day 1). Participants (n=286) were randomized at Day 1 of the Maintenance Phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CAB 30 mg+ABC/3TC QD
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
Denominators
Units
Counts
Participants
BG000309
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00036.6± 10.39
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
Male
BG000282
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
African American/African Heritage
BG00046
American Indian or Alaskan Native
BG000
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).
ITT-ME Population
Posted
Number
Percentage of participants
Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Title
Measurements
OG00095
OG00194
OG00291
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference in Percentage
3.7
2-Sided
95
-4.8
12.2
Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD
Other
OG001
OG002
Primary
Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.
ITT-ME Population
Posted
Count of Participants
Participants
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Primary
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.
Safety Population. It consists of all enrolled subjects who received at least one dose of investigational product during induction period.
Posted
Count of Participants
Participants
Up to 20 weeks
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
Units
Counts
Participants
Primary
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.
Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of investigational product.
Posted
Count of Participants
Participants
Up to an average of 59 weeks
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Primary
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.
Safety Maintenance Population
Posted
Count of Participants
Participants
Up to an average of 59 weeks
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Primary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters
Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Safety Maintenance Population
Posted
Count of Participants
Participants
Up to an average of 59 weeks
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Primary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Safety Maintenance Population
Posted
Count of Participants
Participants
Up to an average of 59 weeks
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Primary
Number of Participants With Post-Baseline Urinalysis Dipstick Results
Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Up to an average of 59 weeks
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Percentage of participants with HIV-1 RNA <200 c/mL and <50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product.
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
Secondary
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Log10 copies per milliliter
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented.
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Cells per cubic millimeter
Week -20, Week -16, Week -12, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Cells per cubic millimeter
Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of IP.
Posted
Count of Participants
Participants
Up to 20 Weeks
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
Secondary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Safety Population. It consists of all enrolled subjects who received at least one dose of IP.
Posted
Count of Participants
Participants
Up to Week 20
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Safety Population
Posted
Count of Participants
Participants
Up to 20 weeks
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
International Units per Liter (IU/L)
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Grams per Liter (G/L)
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Micromoles per Liter (umol/L)
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per Liter (mmol/L)
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
Secondary
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Units per Liter (U/L)
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period)
Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Giga cells per Liter
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
Secondary
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Proportion of red blood cells in blood
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Grams per Liter
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Femtoliters
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
10^12 cells per Liter
Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the induction period.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period)
Percentage of participants with HIV-1 RNA <50 c/mL and <200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders.
ITT-ME Population
Posted
Number
Percentage of participants
From Day 1 up to Week 96
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period)
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.
ITT-ME Population
Posted
Number
Participants
At Week 32 and Week 48
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)
Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented. SD=0.000 is defined as following: if participants analyzed at a specific timepoint have resulted same values, then SD is considered equal with 0.000.
ITT-ME Population. Only those participants available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Log10 copies per milliliter
At Week 32 and Week 96
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)
Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
ITT-ME Population. Only those participants available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Log10 copies per milliliter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.
ITT-ME Population. Only those participants available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Cells per cubic millimeter
At Week 32 and Week 96
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value.
ITT-ME Population. Only those participants available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Cells per cubic millimeter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period)
HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
ITT-ME Population
Posted
Count of Participants
Participants
At Week 32 and Week 96
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
Secondary
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Safety Maintenance Population
Posted
Count of Participants
Participants
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Safety Maintenance Population
Posted
Count of Participants
Participants
Up to Week 96
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
International Units per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Grams per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Micromoles per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Millimoles per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Units per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
10^9 cells per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Proportion of red blood cells in blood
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Grams per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Femtoliters
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Safety Maintenance Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
10^12 cells per Liter
At Week 32 and Week 96 (compared with Baseline [Week -20])
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data.
PK Concentration Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated.
PK Concentration Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Micrograms per milliliter
Pre-dose on Weeks 16, 24 and 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Units
Counts
Participants
Secondary
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Micrograms per milliliter
Pre-dose on Weeks 16, 20, 24, 28 and 32
ID
Title
Description
OG000
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Units
Counts
Participants
Secondary
Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Nanograms per milliliter
Pre-dose on Weeks 16, 24 and 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Units
Counts
Participants
Secondary
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Deviation
Nanograms per milliliter
Pre-dose on Weeks 16, 20, 24, 28 and 32
ID
Title
Description
OG000
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Units
Counts
Participants
Secondary
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC [0-tau]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).
Standard Error (SE)=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000 .
PK Concentration Population. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Error
Change in log odds
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Change in log odds
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
Secondary
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Change in log odds
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).
SE=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Error
Change in log odds
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Change in log odds
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Mean
Standard Error
Change in log odds
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance
Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor [NRTI], Non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI])are presented.
On-trt Genotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment genotypic resistance data, at time of protocol defined virologic failure.
Posted
Count of Participants
Participants
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant.
On-trt Phenotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment phynotypic resistance data, at time of protocol defined virologic failure.
Posted
Count of Participants
Participants
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period)
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).
ITT-ME Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Number
Percentage of participants
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period)
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).
ITT-ME Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Posted
Number
Percentage of participants
Up to Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period)
The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
ITT-ME Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Scores on a scale
At Week 32 and Week 96
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
Secondary
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period)
The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.
ITT-ME Population. Only those participants available at the specified time points were analyzed
Posted
Mean
Standard Deviation
Scores on a scale
Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period)
The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented.
ITT-ME Population. Only those participants available at the specified time points were analyzed
Posted
Count of Participants
Participants
Week 32
ID
Title
Description
OG000
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
Secondary
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period)
The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 96 by their score categories (0: none of the time to 6: all of the time) are presented.
Analysis was performed on the participants that received exclusively an oral regimen during the 96-weeks period [CAB 30mg+ABC/3TC QD (Induction Period and Maintenance Period) group], as pre-specified in Protocol.
Posted
Count of Participants
Participants
Week 96
ID
Title
Description
OG000
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Time Frame
All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks).
Description
Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
1
309
8
309
145
309
EG001
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
0
115
31
115
115
115
EG002
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
3
115
31
115
115
115
EG003
CAB 30 mg+ABC/3TC QD
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
0
56
9
56
52
56
EG004
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
0
34
9
34
34
34
EG005
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
0
10
1
10
10
10
EG006
Long-Term Follow-Up Group
This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
0
43
7
43
7
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG0030 events0 affected56 at risk
EG0040 events0 affected34 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected43 at risk
Suicide attempt
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012 events2 affected115 at risk
EG0022 events1 affected115 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Migraine
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Orchitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG0010 events0 affected115 at risk
EG0022 events2 affected115 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Nerve root compression
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Substance abuse
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Uterine perforation
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012 events2 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Viral infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
COVID-19
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0022 events1 affected115 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Localised infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Malaria
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Shigella infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Drug abuse
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Bipolar I disorder
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Dissociation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Mania
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Psychiatric decompensation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Psychotic behaviour
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Mesenteric vein thrombosis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0022 events2 affected115 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012 events2 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Coma
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Leukoencephalopathy
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Motor neurone disease
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Polyneuropathy alcoholic
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0022 events2 affected115 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Neoplasm prostate
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012 events2 affected115 at risk
EG0022 events2 affected115 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0013 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Splenic vein thrombosis
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Aortic dilatation
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Flushing
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0022 events2 affected115 at risk
EG003
Hernia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Hepatitis alcoholic
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Ischaemic hepatitis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Buried penis syndrome
Congenital, familial and genetic disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Blindness
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Eosinophilic granulomatosis with polyangiitis
Immune system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected115 at risk
EG003
Hypobarism
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Pelvic prolapse
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
VIth nerve paralysis
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Anal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Haematoma
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0012,749 events111 affected115 at risk
EG0023,533 events114 affected115 at risk
EG0030 events0 affected56 at risk
EG004486 events31 affected34 at risk
EG005197 events8 affected10 at risk
EG0064 events4 affected43 at risk
Injection site swelling
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG001209 events41 affected115 at risk
EG002293 events43 affected115 at risk
EG003
Injection site nodule
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG001327 events46 affected115 at risk
EG002675 events57 affected115 at risk
EG003
Injection site induration
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG001156 events32 affected115 at risk
EG002263 events33 affected115 at risk
EG003
Injection site pruritus
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG001285 events40 affected115 at risk
EG002305 events40 affected115 at risk
EG003
Injection site warmth
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG001161 events32 affected115 at risk
EG002218 events29 affected115 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG00019 events19 affected309 at risk
EG00114 events13 affected115 at risk
EG00228 events19 affected115 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00133 events23 affected115 at risk
EG00233 events20 affected115 at risk
EG003
Injection site bruising
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00165 events24 affected115 at risk
EG00293 events18 affected115 at risk
EG003
Asthenia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00114 events8 affected115 at risk
EG00219 events14 affected115 at risk
EG003
Injection site erythema
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00166 events20 affected115 at risk
EG002122 events23 affected115 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events10 affected115 at risk
EG00227 events15 affected115 at risk
EG003
Injection site discolouration
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00120 events7 affected115 at risk
EG00211 events8 affected115 at risk
EG003
Injection site haematoma
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events6 affected115 at risk
EG00269 events13 affected115 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG00027 events27 affected309 at risk
EG001129 events54 affected115 at risk
EG002146 events54 affected115 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00155 events30 affected115 at risk
EG00242 events28 affected115 at risk
EG003
Syphilis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00161 events36 affected115 at risk
EG00246 events28 affected115 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00143 events28 affected115 at risk
EG00236 events23 affected115 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00125 events19 affected115 at risk
EG00226 events17 affected115 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00125 events19 affected115 at risk
EG00232 events21 affected115 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00126 events21 affected115 at risk
EG00245 events32 affected115 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00114 events8 affected115 at risk
EG00217 events11 affected115 at risk
EG003
Gonorrhoea
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00125 events15 affected115 at risk
EG00210 events8 affected115 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0019 events9 affected115 at risk
EG00219 events16 affected115 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00114 events8 affected115 at risk
EG00215 events11 affected115 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00128 events7 affected115 at risk
EG00223 events17 affected115 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00123 events10 affected115 at risk
EG00218 events12 affected115 at risk
EG003
Urethritis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00112 events8 affected115 at risk
EG00216 events11 affected115 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00118 events15 affected115 at risk
EG00211 events10 affected115 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00119 events13 affected115 at risk
EG0027 events7 affected115 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events9 affected115 at risk
EG0027 events6 affected115 at risk
EG003
Ear infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0018 events6 affected115 at risk
EG00211 events9 affected115 at risk
EG003
Viral infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0016 events6 affected115 at risk
EG00210 events9 affected115 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0017 events7 affected115 at risk
EG00210 events9 affected115 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG00216 events11 affected115 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events9 affected115 at risk
EG00220 events12 affected115 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Proctitis chlamydial
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00118 events8 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00121 events11 affected115 at risk
EG0029 events6 affected115 at risk
EG003
Anal chlamydia infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events8 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0018 events6 affected115 at risk
EG0028 events6 affected115 at risk
EG003
Oropharyngeal gonococcal infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00126 events11 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG00210 events8 affected115 at risk
EG003
Proctitis gonococcal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00129 events12 affected115 at risk
EG0029 events7 affected115 at risk
EG003
Urethritis gonococcal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00113 events8 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG00034 events34 affected309 at risk
EG00155 events39 affected115 at risk
EG00259 events35 affected115 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG00038 events38 affected309 at risk
EG00110 events9 affected115 at risk
EG00225 events14 affected115 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00118 events14 affected115 at risk
EG00214 events14 affected115 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0019 events8 affected115 at risk
EG00213 events8 affected115 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG00113 events13 affected115 at risk
EG00210 events7 affected115 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00113 events11 affected115 at risk
EG00215 events11 affected115 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0019 events7 affected115 at risk
EG00212 events11 affected115 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00117 events14 affected115 at risk
EG00213 events12 affected115 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00114 events11 affected115 at risk
EG00210 events7 affected115 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00110 events10 affected115 at risk
EG00211 events10 affected115 at risk
EG003
Anogenital dysplasia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG00210 events8 affected115 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00117 events13 affected115 at risk
EG00219 events14 affected115 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG00027 events27 affected309 at risk
EG00151 events30 affected115 at risk
EG00256 events30 affected115 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00113 events9 affected115 at risk
EG00216 events11 affected115 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00112 events7 affected115 at risk
EG00210 events7 affected115 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG00139 events27 affected115 at risk
EG00255 events30 affected115 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00114 events11 affected115 at risk
EG00218 events13 affected115 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00145 events27 affected115 at risk
EG00234 events21 affected115 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00114 events10 affected115 at risk
EG00219 events14 affected115 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00113 events10 affected115 at risk
EG0028 events6 affected115 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0019 events8 affected115 at risk
EG00210 events9 affected115 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected309 at risk
EG00120 events19 affected115 at risk
EG00215 events14 affected115 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00131 events22 affected115 at risk
EG00224 events20 affected115 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00119 events15 affected115 at risk
EG00215 events11 affected115 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events9 affected115 at risk
EG00213 events11 affected115 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0018 events7 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events9 affected115 at risk
EG0028 events7 affected115 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00126 events19 affected115 at risk
EG00239 events26 affected115 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00117 events14 affected115 at risk
EG00218 events13 affected115 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00120 events14 affected115 at risk
EG00212 events10 affected115 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG00215 events12 affected115 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00110 events7 affected115 at risk
EG00217 events13 affected115 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0017 events6 affected115 at risk
EG0026 events6 affected115 at risk
EG003
Exposure to communicable disease
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00119 events11 affected115 at risk
EG00222 events18 affected115 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00110 events8 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00111 events9 affected115 at risk
EG00210 events9 affected115 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00115 events14 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00112 events10 affected115 at risk
EG00214 events10 affected115 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00112 events11 affected115 at risk
EG0026 events6 affected115 at risk
EG003
COVID-19
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00129 events25 affected115 at risk
EG00234 events28 affected115 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG00113 events9 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0019 events9 affected115 at risk
EG0027 events7 affected115 at risk
EG003
Penis injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected309 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected115 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD
Other
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG000309
Title
Denominators
Categories
Any non-SAE
Title
Measurements
OG000246
Any SAE
Title
Measurements
OG0008
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Any non-SAE
Title
Measurements
OG000115
OG001113
OG00252
Any SAE
Title
Measurements
OG0009
OG0018
OG0025
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Any AE with maximum toxicity Grade 1
Title
Measurements
OG00031
OG00125
OG00219
Any AE with maximum toxicity Grade 2
Title
Measurements
OG00067
OG00172
OG00229
Any AE with maximum toxicity Grade 3
Title
Measurements
OG00015
OG00114
OG0023
Any AE with maximum toxicity Grade 4
Title
Measurements
OG0002
OG0012
OG0021
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Maximum toxicity Grade 1
Title
Measurements
OG00094
OG00194
OG00244
Maximum toxicity Grade 2
Title
Measurements
OG00050
OG00142
OG00216
Maximum toxicity Grade 3
Title
Measurements
OG00015
OG00120
OG00210
Maximum toxicity Grade 4
Title
Measurements
OG00010
OG0017
OG0022
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Maximum toxicity Grade 1
Title
Measurements
OG00023
OG00117
OG0027
Maximum toxicity Grade 2
Title
Measurements
OG0002
OG0014
OG0022
Maximum toxicity Grade 3
Title
Measurements
OG0000
OG0010
OG0022
Maximum toxicity Grade 4
Title
Measurements
OG0000
OG0013
OG0020
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG00020
OG00120
OG00210
Title
Denominators
Categories
Urine Occult Blood, Trace, n=10,11,4
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
Title
Measurements
OG0005
OG0016
OG0021
Urine Occult Blood, 1+, n=10,11,4
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
Title
Measurements
OG000
Urine Occult Blood, 2+, n=10,11,4
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
Title
Measurements
OG000
Urine Occult Blood, 3+, n=10,11,4
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
Title
Measurements
OG000
Urine Occult Blood, Positive, n=10,11,4
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
Title
Measurements
OG000
Urine Glucose, Trace, n=1,1,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG000
Urine Glucose, 1+, n=1,1,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG000
Urine Glucose, 2+, n=1,1,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG000
Urine Glucose, 3+, n=1,1,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG000
Urine Glucose, Positive, n=1,1,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG000
Urine Ketones, Trace, n=16,20,10
ParticipantsOG00016
ParticipantsOG00120
ParticipantsOG00210
Title
Measurements
OG000
Urine Ketones, 1+, n=16,20,10
ParticipantsOG00016
ParticipantsOG00120
ParticipantsOG00210
Title
Measurements
OG000
Urine Ketones, 2+, n=16,20,10
ParticipantsOG00016
ParticipantsOG00120
ParticipantsOG00210
Title
Measurements
OG000
Urine Ketones, 3+, n=16,20,10
ParticipantsOG00016
ParticipantsOG00120
ParticipantsOG00210
Title
Measurements
OG000
Urine Ketones, Positive, n=16,20,10
ParticipantsOG00016
ParticipantsOG00120
ParticipantsOG00210
Title
Measurements
OG000
Urine Nitrite, Trace, n=1,3,1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Urine Nitrite, 1+, n=1,3,1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Urine Nitrite, 2+, n=1,3,1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Urine Nitrite, 3+, n=1,3,1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Urine Nitrite, Positive, n=1,3,1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Urine Protein, Trace, n=17,17,7
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
Title
Measurements
OG000
Urine Protein, 1+, n=17,17,7
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
Title
Measurements
OG000
Urine Protein, 2+, n=17,17,7
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
Title
Measurements
OG000
Urine Protein, 3+, n=17,17,7
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
Title
Measurements
OG000
Urine Protein, Positive, n=17,17,7
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
Title
Measurements
OG000
Urine Leukocyte, Trace, n=20,20,8
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG0028
Title
Measurements
OG000
Urine Leukocyte, 1+, n=20,20,8
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG0028
Title
Measurements
OG000
Urine Leukocyte, 2+, n=20,20,8
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG0028
Title
Measurements
OG000
Urine Leukocyte, 3+, n=20,20,8
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG0028
Title
Measurements
OG000
Urine Leukocyte, Positive, n=20,20,8
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG0028
Title
Measurements
OG000
OG000309
Title
Denominators
Categories
HIV-1 RNA<50 c/mL, Week -20
Title
Measurements
OG0000
HIV-1 RNA<50 c/mL, Week -16
Title
Measurements
OG00072
HIV-1 RNA<50 c/mL, Week -12
Title
Measurements
OG00090
HIV-1 RNA<50 c/mL, Week -8
Title
Measurements
OG00089
HIV-1 RNA<50 c/mL, Week -4
Title
Measurements
OG00092
HIV-1 RNA<50 c/mL, Day 1
Title
Measurements
OG00091
HIV-1 RNA<200 c/mL, Week -20
Title
Measurements
OG0000
HIV-1 RNA<200 c/mL, Week -16
Title
Measurements
OG00094
HIV-1 RNA<200 c/mL, Week -12
Title
Measurements
OG00097
HIV-1 RNA<200 c/mL, Week -8
Title
Measurements
OG00096
HIV-1 RNA<200 c/mL, Week -4
Title
Measurements
OG00094
HIV-1 RNA<200 c/mL, Day 1
Title
Measurements
OG00094
309
Title
Denominators
Categories
Week -20, n=309
ParticipantsOG000309
Title
Measurements
OG0004.43± 0.672
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG0001.71± 0.229
Week -12, n=302
ParticipantsOG000302
Title
Measurements
OG0001.62± 0.108
Week -8, n=299
ParticipantsOG000299
Title
Measurements
OG0001.63± 0.281
Week -4, n=294
ParticipantsOG000294
Title
Measurements
OG0001.61± 0.080
Day 1, n=291
ParticipantsOG000291
Title
Measurements
OG0001.60± 0.070
304
Title
Denominators
Categories
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG000-2.72± 0.572
Week -12, n=302
ParticipantsOG000302
Title
Measurements
OG000-2.80± 0.640
Week -8, n=299
ParticipantsOG000299
Title
Measurements
OG000-2.79± 0.665
Week -4, n=294
ParticipantsOG000294
Title
Measurements
OG000-2.81± 0.647
Day 1, n=291
ParticipantsOG000291
Title
Measurements
OG000-2.82± 0.645
309
Title
Denominators
Categories
Week -20, n=309
ParticipantsOG000309
Title
Measurements
OG000498.9± 180.67
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG000630.5± 235.09
Week -12, n=300
ParticipantsOG000300
Title
Measurements
OG000664.2± 256.57
Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG000702.3± 269.60
Day 1, n=291
ParticipantsOG000291
Title
Measurements
OG000690.9± 261.63
304
Title
Denominators
Categories
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG000131.7± 172.69
Week -12, n=300
ParticipantsOG000300
Title
Measurements
OG000164.5± 174.61
Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG000201.5± 195.53
Day 1, n=291
ParticipantsOG000291
Title
Measurements
OG000188.7± 186.69
OG00056
Title
Denominators
Categories
Maximum toxicity Grade 1
Title
Measurements
OG00027
Maximum toxicity Grade 2
Title
Measurements
OG00015
Maximum toxicity Grade 3
Title
Measurements
OG0002
Maximum toxicity Grade 4
Title
Measurements
OG0001
309
Title
Denominators
Categories
Maximum toxicity Grade 1
Title
Measurements
OG00026
Maximum toxicity Grade 2
Title
Measurements
OG0004
Maximum toxicity Grade 3
Title
Measurements
OG0001
Maximum toxicity Grade 4
Title
Measurements
OG0003
309
Title
Denominators
Categories
Maximum toxicity Grade 1
Title
Measurements
OG000130
Maximum toxicity Grade 2
Title
Measurements
OG00050
Maximum toxicity Grade 3
Title
Measurements
OG00016
Maximum toxicity Grade 4
Title
Measurements
OG0005
306
Title
Denominators
Categories
ALT, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0000.4± 33.1
ALT, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG000-1.3± 14.1
ALT, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG000-0.5± 16.6
ALT, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0001.5± 50.3
ALT, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG000-1.2± 18.0
ALP, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG000-2.1± 12.0
ALP, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG000-2.6± 11.0
ALP, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG000-1.2± 13.0
ALP, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0000.1± 15.4
ALP, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG0000.1± 14.1
AST, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0000.3± 33.4
AST, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG000-2.2± 13.1
AST, Week -8, n=296
ParticipantsOG000296
Title
Measurements
OG000-1.7± 15.8
AST, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG000-0.0± 30.9
AST, Day 1, n=286
ParticipantsOG000286
Title
Measurements
OG000-1.0± 25.9
CK, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG00019.0± 345.6
CK, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG00029.4± 485.4
CK, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG00026.3± 529.6
CK, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG00033.2± 434.2
CK, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG00069.9± 1164.7
306
Title
Denominators
Categories
Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0000.2± 2.3
Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG0000.7± 2.3
Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0001.4± 2.6
Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0001.7± 2.6
Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG0001.9± 2.8
306
Title
Denominators
Categories
Total Bilirubin, Week -16, n=305
ParticipantsOG000305
Title
Measurements
OG000-0.6± 4.5
Total Bilirubin, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG000-0.9± 4.0
Total Bilirubin, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG000-1.0± 4.1
Total Bilirubin, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG000-0.5± 4.1
Total Bilirubin, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG000-0.3± 4.0
Creatinine, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0002.6± 7.6
Creatinine, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG0001.5± 7.8
Creatinine, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0001.6± 7.8
Creatinine, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0003.5± 8.7
Creatinine, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG0004.6± 9.1
OG000306
Title
Denominators
Categories
CO2, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0000.2± 2.4
CO2, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG0000.3± 2.3
CO2, Week -8, n=296
ParticipantsOG000296
Title
Measurements
OG0000.4± 2.3
CO2, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0000.1± 2.3
CO2, Day 1, n=286
ParticipantsOG000286
Title
Measurements
OG000-0.8± 2.6
Chloride, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0000.2± 2.3
Chloride, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG0000.5± 2.2
Chloride, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.6± 2.3
Chloride, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0000.2± 2.3
Chloride, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG0000.2± 2.3
Cholesterol, Week -16, n=255
ParticipantsOG000255
Title
Measurements
OG0000.21± 0.6
Cholesterol, Week -12, n=236
ParticipantsOG000236
Title
Measurements
OG0000.19± 0.5
Cholesterol, Week -8, n=235
ParticipantsOG000235
Title
Measurements
OG0000.27± 0.5
Cholesterol, Week -4, n=282
ParticipantsOG000282
Title
Measurements
OG0000.34± 0.5
Cholesterol, Day 1, n=285
ParticipantsOG000285
Title
Measurements
OG0000.34± 0.6
Glucose, Week -16, n=255
ParticipantsOG000255
Title
Measurements
OG0000.07± 0.7
Glucose, Week -12, n=236
ParticipantsOG000236
Title
Measurements
OG0000.16± 0.7
Glucose, Week -8, n=235
ParticipantsOG000235
Title
Measurements
OG0000.08± 0.7
Glucose, Week -4, n=281
ParticipantsOG000281
Title
Measurements
OG0000.06± 0.7
Glucose, Day 1, n=282
ParticipantsOG000282
Title
Measurements
OG000-0.01± 0.7
Potassium, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG000-0.05± 0.2
Potassium, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG000-0.03± 0.3
Potassium, Week -8, n=296
ParticipantsOG000296
Title
Measurements
OG0000.03± 0.3
Potassium, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0000.03± 0.3
Potassium, Day 1, n=286
ParticipantsOG000286
Title
Measurements
OG0000.03± 0.3
Sodium, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG000-0.1± 1.8
Sodium, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG0000.1± 1.8
Sodium, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.2± 1.9
Sodium, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0000.4± 2.0
Sodium, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG0000.3± 1.9
Triglyceride, Week -16, n=3
ParticipantsOG0003
Title
Measurements
OG000-0.69± 0.1
Triglyceride, Week -12, n=2
ParticipantsOG0002
Title
Measurements
OG000-0.37± 0.1
Triglyceride, Week -8, n=2
ParticipantsOG0002
Title
Measurements
OG0000.29± 0.4
Triglyceride, Week -4, n=278
ParticipantsOG000278
Title
Measurements
OG0000.20± 0.9
Triglyceride, Day 1, n=278
ParticipantsOG000278
Title
Measurements
OG000-0.00± 0.7
Urea, Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG000-0.06± 1.2
Urea, Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG000-0.08± 1.2
Urea, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG000-0.09± 1.1
Urea, Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG000-0.12± 1.3
Urea, Day 1, n=287
ParticipantsOG000287
Title
Measurements
OG0000.00± 1.2
306
Title
Denominators
Categories
Week -16, n=306
ParticipantsOG000306
Title
Measurements
OG0003.3± 20.0
Week -12, n=301
ParticipantsOG000301
Title
Measurements
OG0000.8± 15.3
Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0002.8± 24.3
Week -4, n=292
ParticipantsOG000292
Title
Measurements
OG0002.1± 23.8
Day 1, n=288
ParticipantsOG000288
Title
Measurements
OG000-1.2± 17.7
OG000303
Title
Denominators
Categories
Basophils, Week -16, n=303
ParticipantsOG000303
Title
Measurements
OG0000.00± 0.016
Basophils, Week -12, n=298
ParticipantsOG000298
Title
Measurements
OG0000.00± 0.019
Basophils, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.00± 0.015
Basophils, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0000.00± 0.016
Basophils, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.00± 0.019
Eosinophils, Week -16, n=303
ParticipantsOG000303
Title
Measurements
OG0000.01± 0.131
Eosinophils, Week -12, n=298
ParticipantsOG000298
Title
Measurements
OG0000.01± 0.123
Eosinophils, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.02± 0.127
Eosinophils, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0000.02± 0.136
Eosinophils, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.03± 0.161
Lymphocytes, Week -16, n=303
ParticipantsOG000303
Title
Measurements
OG0000.24± 0.541
Lymphocytes, Week -12, n=298
ParticipantsOG000298
Title
Measurements
OG0000.28± 0.573
Lymphocytes, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.30± 0.541
Lymphocytes, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0000.30± 0.574
Lymphocytes, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.14± 0.565
Monocytes, Week -16, n=303
ParticipantsOG000303
Title
Measurements
OG000-0.00± 0.129
Monocytes, Week -12, n=298
ParticipantsOG000298
Title
Measurements
OG0000.00± 0.139
Monocytes, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG000-0.00± 0.135
Monocytes, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG000-0.00± 0.132
Monocytes, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.00± 0.143
Platelet count, Week -16, n=302
ParticipantsOG000302
Title
Measurements
OG00014.4± 31.56
Platelet count, Week -12, n=300
ParticipantsOG000300
Title
Measurements
OG00018.2± 32.53
Platelet count, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG00021.1± 37.00
Platelet count, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG00023.0± 35.02
Platelet count, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG00022.2± 35.32
Total Neutrophils, Week -16, n=303
ParticipantsOG000303
Title
Measurements
OG0000.04± 1.185
Total Neutrophils, Week -12, n=298
ParticipantsOG000298
Title
Measurements
OG0000.22± 1.391
Total Neutrophils, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.20± 1.286
Total Neutrophils, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0000.31± 1.429
Total Neutrophils, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.38± 1.515
WBC, Week -16, n=303
ParticipantsOG000303
Title
Measurements
OG0000.31± 1.318
WBC, Week -12, n=298
ParticipantsOG000298
Title
Measurements
OG0000.52± 1.522
WBC, Week -8, n=297
ParticipantsOG000297
Title
Measurements
OG0000.54± 1.460
WBC, Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0000.64± 1.594
WBC, Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.57± 1.713
304
Title
Denominators
Categories
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG0000.00± 0.022
Week -12, n=302
ParticipantsOG000302
Title
Measurements
OG0000.00± 0.023
Week -8, n=298
ParticipantsOG000298
Title
Measurements
OG0000.00± 0.024
Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0000.00± 0.025
Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0000.00± 0.025
304
Title
Denominators
Categories
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG0000.8± 6.94
Week -12, n=302
ParticipantsOG000302
Title
Measurements
OG0002.0± 7.07
Week -8, n=298
ParticipantsOG000298
Title
Measurements
OG0002.5± 7.42
Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0003.3± 7.95
Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0003.1± 7.96
304
Title
Denominators
Categories
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG0001.0± 1.52
Week -12, n=302
ParticipantsOG000302
Title
Measurements
OG0002.1± 1.90
Week -8, n=298
ParticipantsOG000298
Title
Measurements
OG0003.1± 2.49
Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG0004.0± 2.47
Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG0004.4± 2.57
304
Title
Denominators
Categories
Week -16, n=304
ParticipantsOG000304
Title
Measurements
OG000-0.05± 0.242
Week -12, n=302
ParticipantsOG000302
Title
Measurements
OG000-0.07± 0.254
Week -8, n=298
ParticipantsOG000298
Title
Measurements
OG000-0.10± 0.266
Week -4, n=290
ParticipantsOG000290
Title
Measurements
OG000-0.10± 0.284
Day 1, n=290
ParticipantsOG000290
Title
Measurements
OG000-0.14± 0.289
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
HIV-1 RNA<50 c/mL, Day 1
Title
Measurements
OG00095
OG00199
OG00298
HIV-1 RNA<50 c/mL, Week 4
Title
Measurements
OG00097
OG00198
OG00293
HIV-1 RNA<50 c/mL, Week 8
Title
Measurements
OG00098
OG00197
OG00295
HIV-1 RNA<50 c/mL, Week 12
Title
Measurements
OG00096
OG00197
OG00298
HIV-1 RNA<50 c/mL, Week 16
Title
Measurements
OG00097
OG00196
OG00289
HIV-1 RNA<50 c/mL, Week 20
Title
Measurements
OG00097
OG00197
OG00291
HIV-1 RNA<50 c/mL, Week 24
Title
Measurements
OG00096
OG00194
OG00291
HIV-1 RNA<50 c/mL, Week 28
Title
Measurements
OG00090
OG00192
OG00286
HIV-1 RNA<50 c/mL, Week 32
Title
Measurements
OG00095
OG00194
OG00291
HIV-1 RNA<50 c/mL, Week 36
Title
Measurements
OG00095
OG00190
OG00288
HIV-1 RNA<50 c/mL, Week 40
Title
Measurements
OG00092
OG00191
OG00286
HIV-1 RNA<50 c/mL, Week 44
Title
Measurements
OG00093
OG00190
OG00288
HIV-1 RNA<50 c/mL, Week 48
Title
Measurements
OG00092
OG00191
OG00289
HIV-1 RNA<50 c/mL, Week 56
Title
Measurements
OG00094
OG00190
OG00284
HIV-1 RNA<50 c/mL, Week 64
Title
Measurements
OG00095
OG00190
OG00286
HIV-1 RNA<50 c/mL, Week 72
Title
Measurements
OG00095
OG00190
OG00288
HIV-1 RNA<50 c/mL, Week 80
Title
Measurements
OG00095
OG00187
OG00284
HIV-1 RNA<50 c/mL, Week 88
Title
Measurements
OG00095
OG00186
OG00284
HIV-1 RNA<50 c/mL, Week 96
Title
Measurements
OG00094
OG00187
OG00284
HIV-1 RNA<200 c/mL, Day 1
Title
Measurements
OG000100
OG001100
OG00298
HIV-1 RNA<200 c/mL, Week 4
Title
Measurements
OG00099
OG001100
OG00296
HIV-1 RNA<200 c/mL, Week 8
Title
Measurements
OG00099
OG00199
OG00295
HIV-1 RNA<200 c/mL, Week 12
Title
Measurements
OG00097
OG00198
OG00298
HIV-1 RNA<200 c/mL, Week 16
Title
Measurements
OG00098
OG00198
OG00293
HIV-1 RNA<200 c/mL, Week 20
Title
Measurements
OG00098
OG00197
OG00293
HIV-1 RNA<200 c/mL, Week 24
Title
Measurements
OG00097
OG00196
OG00293
HIV-1 RNA<200 c/mL, Week 28
Title
Measurements
OG00094
OG00195
OG00291
HIV-1 RNA<200 c/mL, Week 32
Title
Measurements
OG00097
OG00195
OG00291
HIV-1 RNA<200 c/mL, Week 36
Title
Measurements
OG00097
OG00193
OG00289
HIV-1 RNA<200 c/mL, Week 40
Title
Measurements
OG00097
OG00192
OG00286
HIV-1 RNA<200 c/mL, Week 44
Title
Measurements
OG00095
OG00191
OG00289
HIV-1 RNA<200 c/mL, Week 48
Title
Measurements
OG00097
OG00192
OG00289
HIV-1 RNA<200 c/mL, Week 56
Title
Measurements
OG00096
OG00190
OG00286
HIV-1 RNA<200 c/mL, Week 64
Title
Measurements
OG00096
OG00190
OG00288
HIV-1 RNA<200 c/mL, Week 72
Title
Measurements
OG00096
OG00190
OG00288
HIV-1 RNA<200 c/mL, Week 80
Title
Measurements
OG00096
OG00188
OG00284
HIV-1 RNA<200 c/mL, Week 88
Title
Measurements
OG00096
OG00186
OG00284
HIV-1 RNA<200 c/mL, Week 96
Title
Measurements
OG00096
OG00187
OG00284
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Week 32
Title
Measurements
OG0001
OG0010
OG0021
Week 48
Title
Measurements
OG0002
OG0010
OG0021
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000111
OG001108
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000111
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG0001.60± 0.044
OG0011.59± 0.025
OG0021.61± 0.112
Week 96
ParticipantsOG000110
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000111
OG001108
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000111
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000-2.78± 0.610
OG001-2.88± 0.709
OG002-2.73± 0.561
Week 96
ParticipantsOG000110
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000752.3± 318.02
OG001761.3± 293.07
OG002891.3± 273.32
Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000264.4± 247.84
OG001263.7± 217.74
OG002346.1± 219.59
Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
From CDC Stage 1 to CDC Stage 3 Event, Week 32
Title
Measurements
OG0001
OG0010
OG0020
From CDC Stage 2 to CDC Stage 3 Event, Week 32
Title
Measurements
OG0000
OG0010
OG0020
From CDC Stage 3 to New CDC Stage 3 Event, Week 32
Title
Measurements
OG0000
OG0010
OG0020
From CDC Stage 1, 2 or 3 to Death, Week 32
Title
Measurements
OG0000
OG0011
OG0020
From CDC Stage 1 to CDC Stage 3 Event, Week 96
Title
Measurements
OG0004
OG0010
OG0020
From CDC Stage 2 to CDC Stage 3 Event, Week 96
Title
Measurements
OG0000
OG0010
OG0020
From CDC Stage 3 to New CDC Stage 3 Event, Week 96
Title
Measurements
OG0000
OG0010
OG0020
From CDC Stage 1, 2 or 3 to Death, Week 96
Title
Measurements
OG0000
OG0011
OG0020
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Grade 1
Title
Measurements
OG00035
OG00129
OG00223
Grade 2
Title
Measurements
OG00065
OG00169
OG00222
Grade 3
Title
Measurements
OG00014
OG00113
OG0021
Grade 4
Title
Measurements
OG0001
OG0012
OG0020
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000115
OG001115
OG00256
Title
Denominators
Categories
Grade 1
Title
Measurements
OG00023
OG00121
OG00224
Grade 2
Title
Measurements
OG00071
OG00174
OG00226
Grade 3
Title
Measurements
OG00019
OG00118
OG0024
Grade 4
Title
Measurements
OG0002
OG0012
OG0020
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
ALT, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000-2.4± 13.4
OG001-2.7± 13.5
OG002-5.0± 19.5
ALP, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
AST, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
CK, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
ALT, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
ALP, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
AST, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
CK, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG0001.4± 3.0
OG0010.9± 2.9
OG0021.1± 2.8
Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
Total Bilirubin, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG0000.8± 4.4
OG0010.4± 3.6
OG002-0.6± 4.4
Creatinine, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
Total Bilirubin, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
Creatinine, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
Total CO2, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000-0.8± 2.1
OG001-1.5± 2.4
OG002-1.1± 2.4
Chloride, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
Cholesterol, Week 32
ParticipantsOG000109
ParticipantsOG001106
ParticipantsOG00250
Title
Measurements
OG000
Glucose, Week 32
ParticipantsOG000109
ParticipantsOG001106
ParticipantsOG00250
Title
Measurements
OG000
Potassium, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
Sodium, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
Triglycerides, Week 32
ParticipantsOG000107
ParticipantsOG001105
ParticipantsOG00250
Title
Measurements
OG000
Urea, Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000
Total CO2, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
Chloride, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
Cholesterol, Week 96
ParticipantsOG000105
ParticipantsOG00196
ParticipantsOG00246
Title
Measurements
OG000
Glucose, Week 96
ParticipantsOG000106
ParticipantsOG00196
ParticipantsOG00246
Title
Measurements
OG000
Potassium, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
Sodium, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
Triglycerides, Week 96
ParticipantsOG000103
ParticipantsOG00195
ParticipantsOG00246
Title
Measurements
OG000
Urea, Week 96
ParticipantsOG000109
ParticipantsOG001100
ParticipantsOG00247
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000112
OG001108
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000112
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000-1.2± 33.2
OG001-4.4± 15.4
OG002-3.9± 14.7
Week 96
ParticipantsOG000109
ParticipantsOG001101
ParticipantsOG00247
Title
Measurements
OG000
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000110
OG001107
OG00248
Title
Denominators
Categories
Basophils, Week 32
ParticipantsOG000110
ParticipantsOG001106
ParticipantsOG00248
Title
Measurements
OG0000.00± 0.012
OG001-0.00± 0.022
OG0020.00± 0.010
Eosinophils, Week 32
ParticipantsOG000110
ParticipantsOG001106
ParticipantsOG00248
Title
Measurements
OG000
Lymphocytes, Week 32
ParticipantsOG000110
ParticipantsOG001106
ParticipantsOG00248
Title
Measurements
OG000
Monocytes, Week 32
ParticipantsOG000110
ParticipantsOG001106
ParticipantsOG00248
Title
Measurements
OG000
Platelet count, Week 32
ParticipantsOG000110
ParticipantsOG001107
ParticipantsOG00248
Title
Measurements
OG000
Total Neutrophils, Week 32
ParticipantsOG000110
ParticipantsOG001106
ParticipantsOG00248
Title
Measurements
OG000
WBC count, Week 32
ParticipantsOG000110
ParticipantsOG001106
ParticipantsOG00248
Title
Measurements
OG000
Basophils, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
Eosinophils, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
Lymphocytes, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
Monocytes, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
Platelet count, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00246
Title
Measurements
OG000
Total Neutrophils, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
WBC count, Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000111
OG001107
OG00248
Title
Denominators
Categories
Week 32
ParticipantsOG000111
ParticipantsOG001107
ParticipantsOG00248
Title
Measurements
OG0000.01± 0.026
OG0010.01± 0.027
OG0020.01± 0.027
Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000111
OG001107
OG00248
Title
Denominators
Categories
Week 32
ParticipantsOG000111
ParticipantsOG001107
ParticipantsOG00248
Title
Measurements
OG0002.0± 8.56
OG0010.8± 8.45
OG0021.7± 8.38
Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000111
OG001107
OG00248
Title
Denominators
Categories
Week 32
ParticipantsOG000111
ParticipantsOG001107
ParticipantsOG00248
Title
Measurements
OG0002.5± 1.97
OG0012.3± 2.54
OG0027.1± 2.88
Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000111
OG001107
OG00248
Title
Denominators
Categories
Week 32
ParticipantsOG000111
ParticipantsOG001107
ParticipantsOG00248
Title
Measurements
OG0000.03± 0.286
OG0010.02± 0.278
OG002-0.20± 0.296
Week 96
ParticipantsOG000110
ParticipantsOG001101
ParticipantsOG00248
Title
Measurements
OG000
Units
Counts
Participants
OG000115
OG001115
Title
Denominators
Categories
C0
Title
Measurements
OG0001.43± 54
OG0012.35± 32
Cmax
Title
Measurements
OG0003.55± 56
OG0013.50± 39
Units
Counts
Participants
OG000115
OG001115
Title
Denominators
Categories
C0
Title
Measurements
OG00049.3± 41
OG00177.2± 35
Cmax
Title
Measurements
OG000104± 47
OG001111± 40
OG00087
Title
Denominators
Categories
Week 16, n=87
ParticipantsOG00087
Title
Measurements
OG0001.6902± 0.80471
Week 24, n=86
ParticipantsOG00086
Title
Measurements
OG0001.6051± 0.78254
Week 32, n=84
ParticipantsOG00084
Title
Measurements
OG0001.5330± 0.70822
OG000
85
Title
Denominators
Categories
Week 16, n=78
ParticipantsOG00078
Title
Measurements
OG0002.2703± 0.92102
Week 20, n=77
ParticipantsOG00077
Title
Measurements
OG0002.3861± 0.76176
Week 24, n=78
ParticipantsOG00078
Title
Measurements
OG0002.6342± 1.29093
Week 28, n=82
ParticipantsOG00082
Title
Measurements
OG0002.4365± 0.86420
Week 32, n=85
ParticipantsOG00085
Title
Measurements
OG0002.4715± 0.89893
OG00087
Title
Denominators
Categories
Week 16, n=87
ParticipantsOG00087
Title
Measurements
OG00041.94± 17.575
Week 24, n=85
ParticipantsOG00085
Title
Measurements
OG00047.97± 22.341
Week 32, n=83
ParticipantsOG00083
Title
Measurements
OG00057.24± 22.926
OG000
85
Title
Denominators
Categories
Week 16, n=78
ParticipantsOG00078
Title
Measurements
OG00066.92± 25.986
Week 20, n=77
ParticipantsOG00077
Title
Measurements
OG00074.55± 29.156
Week 24, n=78
ParticipantsOG00078
Title
Measurements
OG00076.84± 27.976
Week 28, n=83
ParticipantsOG00083
Title
Measurements
OG00080.84± 31.297
Week 32, n=85
ParticipantsOG00085
Title
Measurements
OG00090.34± 34.549
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG00086
OG00184
OG0020
Title
Denominators
Categories
CAB LA
Title
Measurements
OG0000.00± 0.001
OG0010.00± 0.002
RPV LA
Title
Measurements
OG0000.00± 0.000
OG0010.00± 0.000
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000101
OG001108
OG00250
Title
Denominators
Categories
CAB LA, n=100,108, 50
ParticipantsOG000100
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG0000.64± 0.837
OG0012.39± 1.903
OG0020.39± 0.528
RPV LA, n=101,104,49
ParticipantsOG000101
ParticipantsOG001104
ParticipantsOG00249
Title
Measurements
OG000
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG00098
OG00197
OG0020
Title
Denominators
Categories
CAB LA, n=98, 97,0
ParticipantsOG00098
ParticipantsOG00197
ParticipantsOG0020
Title
Measurements
OG000-0.01± 0.174
OG0011.64± 1.707
RPV LA, n=97,96,0
ParticipantsOG00097
ParticipantsOG00196
ParticipantsOG0020
Title
Measurements
OG000
OG001
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG00086
OG00184
OG0020
Title
Denominators
Categories
CAB LA
Title
Measurements
OG000-0.00± 0.001
OG001-0.00± 0.002
RPV LA
Title
Measurements
OG0000.00± 0.000
OG001-0.00± 0.000
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000101
OG001108
OG00250
Title
Denominators
Categories
CAB LA, n=100,108, 50
ParticipantsOG000100
ParticipantsOG001108
ParticipantsOG00250
Title
Measurements
OG000-1.01± 1.014
OG001-2.39± 1.903
OG002-0.53± 0.796
RPV LA, n=101,104,49
ParticipantsOG000101
ParticipantsOG001104
ParticipantsOG00249
Title
Measurements
OG000
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG00098
OG00197
OG0020
Title
Denominators
Categories
CAB LA, n=98, 97,0
ParticipantsOG00098
ParticipantsOG00197
ParticipantsOG0020
Title
Measurements
OG000-0.45± 0.509
OG001-1.64± 1.707
RPV LA, n=97,96,0
ParticipantsOG00097
ParticipantsOG00196
ParticipantsOG0020
Title
Measurements
OG000
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG0001
OG0010
OG0021
Title
Denominators
Categories
INI mutations
Title
Measurements
OG0000
OG0020
Major mutations of other classes
Title
Measurements
OG0000
OG0020
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG0001
OG0010
OG0021
Title
Denominators
Categories
INI, Sensitive
Title
Measurements
OG0001
OG0021
INI, Partially sensitive
Title
Measurements
OG0000
OG0020
INI, Resistant
Title
Measurements
OG0000
OG0020
NNRTI, Sensitive
Title
Measurements
OG0001
OG0021
NNRTI, Partially sensitive
Title
Measurements
OG0000
OG0020
NNRTI, Resistant
Title
Measurements
OG0000
OG0020
NRTI, Sensitive
Title
Measurements
OG0001
OG0021
NRTI, Partially sensitive
Title
Measurements
OG0000
OG0020
NRTI, Resistant
Title
Measurements
OG0000
OG0020
PI, Sensitive
Title
Measurements
OG0001
OG0021
PI, Partially sensitive
Title
Measurements
OG0000
OG0020
PI, Resistant
Title
Measurements
OG0000
OG0020
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000109
OG001106
OG00250
Title
Denominators
Categories
Week 32
ParticipantsOG000109
ParticipantsOG001106
ParticipantsOG00250
Title
Measurements
OG00068.4± 4.48
OG00166.6± 6.47
OG00265.1± 5.83
Week 96
ParticipantsOG000108
ParticipantsOG001100
ParticipantsOG00246
Title
Measurements
OG000
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Units
Counts
Participants
OG000106
OG001100
OG00249
Title
Denominators
Categories
Title
Measurements
OG00030.9± 7.56
OG00128.9± 8.53
OG00220.5± 14.09
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
OG002
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).